FDA WARNING_LETTER - Euphoria Fancy Food Inc - August 04, 2011

On August 1 and 4, 2011, the FDA inspected Euphoria Fancy Food Inc., a seafood importer in Brooklyn, New York, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. Specifically, the firm failed to implement an affirmative step to ensure imported fish and fishery products are processed in accordance with HACCP regulations, as required by 21 CFR 123.12(a)(2)(ii).

This violation was identified for products including (b)(4) Herring Special Salting from Etalon, Russia, and Marinated Sprat with Sunflower Oil from Zao Rybny Dvor, Russia. Due to these deficiencies, the imported seafood products are considered adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)), as they were prepared, packed, or held under insanitary conditions.

The FDA warned that failure to promptly correct these violations could lead to further action, including refusal of admission for imported products, "detention without physical examination," product seizure, and/or injunctions. The firm was required to respond in writing within fifteen working days, outlining specific corrective actions, including documentation of HACCP and importer verification records, and affirmative step performance. The letter also noted that this list of